Covaxin to Get WHO Approval at the Earliest: Bharat Biotech
Bharat Biotech said Covaxin has overall efficacy of 77.8%.
Indian drugmaker Bharat Biotech on Monday, 12 June, said that the pharmaceutical company expects to receive emergency use listing (EUL) for its COVID-19 vaccine, Covaxin, from the World Health Organization (WHO) very soon.
"The review process has now commenced with the expectation that we will receive EUL from WHO at the earliest," Bharat Biotech stated in an official release.
"All documents required for Emergency Use Listing (EUL) of Covaxin have been submitted to WHO as of 9 July."Bharat Biotech
Covaxin, India's first fully home-grown COVID-19 vaccine, has overall efficacy of 77.8 percent, Bharat Biotech had announced on 3 July.
The final-phase (phase 3) clinical trial results released by the company also indicated that the vaccine was 65.2 percent effective against the Delta variant of the coronavirus.
What is Emergency Use Listing (EUL)?
WHO's EUL assesses the quality, safety and efficacy of COVID-19 vaccines, as well as their risk management plans and programmatic suitability, such as cold chain requirements.
The EUL is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics, and in-vitro diagnostics, with the ultimate aim of expediting the availability of these products to people affected by a public health emergency.
The assessment is performed by a product evaluation group, composed by regulatory experts from around the world, and a Technical Advisory Group (TAG), which is in charge of performing the risk-benefit assessment for an independent recommendation on whether a vaccine can be listed for emergency use and, if so, under what conditions.
WHO’s Emergency Use Listing (EUL) is a prerequisite for COVAX Facility vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.
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